Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, one-arm, phase II clinical study of Tislelizumab Combined With Anlotinib and Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Criteria

Inclusion Criteria:

• Advanced or metastatic pancreatic adenocarcinoma diagnosed by pathology;

• Previously received a standard first-line chemotherapy regimen of pancreatic cancer

• Age ≥ 18 and≤ 75 years old;

• Expected survival ≥ 3 months;

• ECOG score 0-1;

• Child-Pugh score < 8;

• There is at least one measurable tumor lesion: the long diameter is ≥10 mm, and the short diameter of lymph nodes is ≥15 mm;

• The results of liver and kidney function and blood routine examination within 1 week before enrollment meet the following conditions:

Neutrophils (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 80×109/L, hemoglobin (HGB) ≥ 80g/L; Serum creatinine (Cr) ≤ 1.5 × upper limit of normal value; total bilirubin (TBIL) ≤ 2.5 × upper limit of normal value, Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5× upper limit of normal value;

• The patient voluntarily participated in this study and signed the informed consent form.

Exclusion Criteria:

• Received other immunotherapy previously(including immune checkpoint inhibitor PD-1/PDL1 and other immune checkpoint inhibitors) and/or anti-angiogenic drugs (including anti-VEGFR monoclonal antibody and anti-angiogenic small molecule kinase inhibitors) ; Known to be severely allergic to the drugs used in the study of tislelizumab and anlotinib;

• Patients with obstructive jaundice who cannot reach TBIL ≤ 2.5 times the upper limit of normal value after surgical intervention;

• Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;

• Obvious blood coagulation disorder, active bleeding and bleeding tendency;

• There is a history of other malignant tumors within 5 years (adequately treated skin basal cell carcinoma, cervical in situ);

• Interstitial pneumonia or pulmonary fibrosis;

• Uncontrollable pleural effusion or ascites;

• Severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months);

• During pregnancy or breastfeeding, and those who refuse to take appropriate contraceptive measures during the test;

• Patients judged by the investigator to be inappropriate to participate in this study.